MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS BIO-MEDICUS NG 15 FR ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96570-115

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem Perforation of Vessels (2135)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: visual inspection shows the device is labeled as a 19 french and the peel pouch is labeled as a 15 french.The device was measured to be a 19 french.Conclusion: after investigation at medtronic, the complaint for an incorrect cannula model within the package was confirmed.Instead of a model 96570-115 (15 french), a model number 96570-119 (19 french) was in the packaging.The 96570-119 cannula was printed as a 19 french cannula and measured as a 19 french cannula size.The introducer packaged with the 96570-119 cannula was the correct size for the 96570-115 device.The package labeling was correct for the finished good lot associated with the 96570-115 cannula model and matched the device history record.The device history record was reviewed; no abnormalities were documented during the manufacture of this product.An investigation into the root cause of this occurrence is ongoing.As a result of the investigation findings, corrective and preventative actions will be taken.(b)(4).

Event Description

Medtronic received information indicating that during a procedure the customer opened a cannula package labeled as 15 french, but the pack contained a 19 french version of the same cannula.Although aware of the size difference, the customer attempted to insert the 19 french cannula into the vessel.During the attempted placement, the patient's right femoral artery was perforated.The surgeon repaired the damaged vessel and the patient recovered from the procedure with no additional adverse effects.

• Brand Name: BIO-MEDICUS NG 15 FR ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5256336
• MDR Text Key: 32351280
• Report Number: 2184009-2015-00118
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 96570-115
• Device Catalogue Number: 96570-115
• Device Lot Number: 209828442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention